Parexel Blog

Parexel Blog

  • Decentralized Trials: Considerations for Building a New Patient-Centric Model

    Decentralized Trials: Considerations for Building a New Patient-Centric Model

    During the past year, patients around the world waiting for new treatments have taken heart that clinical trials have been ongoing, despite the enormous logistical challenges posed by the...

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  • PBPK modeling solutions as a potential risk mitigation strategy for pH dependent DDIs

    PBPK modeling solutions as a potential risk mitigation strategy for pH dependent DDIs

    Drug- Drug Interaction (DDI) is a crucial aspect in new drug development due potential impact on patients’ safety. Pharmacokinetic interactions at the level of absorption, distribution, metabolism...

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  • On the precipice of an impending avalanche of regulatory compliance activity: Are you prepared?

    On the precipice of an impending avalanche of regulatory compliance activity: Are you prepared?

    The COVID-19 pandemic brought into sharp focus the vulnerabilities in supply chains for medical products and the importance of ensuring their integrity to provide patient access to critical...

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  • Leveraging the draft FDA Guidance on PBPK for your drug development program

    Leveraging the draft FDA Guidance on PBPK for your drug development program

    In October of 2020, the Food and Drug Administration (FDA) issued draft guidance for the pharmaceutical industry on The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics...

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  • We need faster endpoints for targeted cancer drugs, and there is one

    We need faster endpoints for targeted cancer drugs, and there is one

    As a former regulator, Jorge shares his perspectives for the need of more faster endpoints to measure how targeted cancer drugs can benefit patients. He believes it can be created by combining two...

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  • Three ways to improve your chances that insurers will pay for a new CGT

    Three ways to improve your chances that insurers will pay for a new CGT

    When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients...

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  • Getting the small steps right for our biotech customers to make an exponential difference in patients’ lives

    Getting the small steps right for our biotech customers to make an exponential difference in patients’ lives

    Biotech companies are the driving force behind the industry’s R&D pipeline as they develop and launch increasingly complex treatments. With more than 80% of the assets in development managed by...

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  • Set Your Organization and FDA Up for Compliance Success in Shifting Times

    Set Your Organization and FDA Up for Compliance Success in Shifting Times

    Once the full fury of the pandemic was understood, the Food and Drug Administration turned to a number of tools that already existed to help fill the gap for information that was normally...

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  • Will FDA Regulation of Cannabidiol (CBD) Consumer Products Change?

    Will FDA Regulation of Cannabidiol (CBD) Consumer Products Change?

    Now that the presidential election in the United States has come and gone and there will be an expected change in administrations in January, 2021 one of the questions that has been raised is...

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  • Episode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical Insights

    Episode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical Insights

    Pediatric participation in clinical trials is essential to understanding how drugs perform in children, whose side effects and responses to medications are often very different from adults. Yet...

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  • Third Time’s the Charm – FDA Publishes Final Guidance on Insanitary Conditions

    Third Time’s the Charm – FDA Publishes Final Guidance on Insanitary Conditions

    In the Federal Register notice, FDA reiterated that drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients.

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  • Challenges of 2020: Lessons for Clinical Trials in Diabetes

    Challenges of 2020: Lessons for Clinical Trials in Diabetes

    The extraordinary challenges of 2020—the global pandemic and the renewed campaign against racial injustice—have simultaneously presented opportunities for significant growth and change across the...

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  • Fostering steady advances in data operations: FSP partnerships can spur and support change

    Fostering steady advances in data operations: FSP partnerships can spur and support change

    When we discuss innovation in clinical trials, it’s easy to think first of technologies involving digital health or evolving tools such as augmented intelligence. And these are certainly...

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  • The long and winding road for quality metrics takes another turn

    The long and winding road for quality metrics takes another turn

    In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).

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  • Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and...

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  • Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

    Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

    Despite the best efforts of the pandemic, the FDLI delayed but did not cancel its annual meeting for 2020 and hosted the event through a virtual platform. In this blog, I’ll walk through the...

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  • The Evolving Cell and Gene Therapy (CGT) Sector in China

    The Evolving Cell and Gene Therapy (CGT) Sector in China

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  • Optimizing SOPS in the Digital World

    Optimizing SOPS in the Digital World

    For any company on the receiving end of an FDA 483 or warning letter, standard operating procedures (SOPs) represent an opportunity to simultaneously achieve compliance and improve operational...

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  • Never Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities

    Never Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities

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  • I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    FDA has previously made several public statements about its ability to conduct inspections and FDA personnel have also made policy comments in various public forums. Now that this guidance has...

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